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Feasibility of a Self-guided Exercise Program Among Hospitalized COVID-19 Patients

Primary Purpose

Corona Virus Infection

Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PT Pal
Exercise Manual
Sponsored by
Montefiore Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Corona Virus Infection focused on measuring coronavirus, covid, covid-19, covid19, corona

Eligibility Criteria

18 Years - 89 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion

  • COVID-19 Positive by PCR testing
  • Adults aged 50-75
  • Patients evaluated by Rehabilitation team and found appropriate for the study
  • Able to read and understand English or Spanish
  • Have access to a smartphone

Exclusion

  • Pregnant patients
  • Patients with dementia or cognitive dysfunction
  • Patients who exhibit poor safety or unsafe behavior
  • Patients who need high flow oxygen, rebreather or any form of ventilatory support
  • Patients with chest tubes or similar attachments

Sites / Locations

  • Montefiore Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PT Pal

Exercise Manual

Arm Description

Experimental Arm-PT PAL Participants randomized into this arm will receive exercise instructions via Pt_PAL. PT PAL is a mobile health technology used to facilitate communications between Care teams and patients, by allowing the team to send web-based exercise routines, surveys and educational materials. The PT Pal app captures patient activity adherence and reports

Control Arm- Exercise Manual Participants randomized into this arm will use the exercise manual to obtain their exercise instructions

Outcomes

Primary Outcome Measures

Adherence: Number of Days patient exercises independently at least 1 time a day
Recruitment , Implementation and Retention: number of patients contacted, enrolled and completed study
Safety: Number of adverse health events

Secondary Outcome Measures

Activity Measure for Post-Acute Care (AM-PAC).
The range is 6-24; higher scores reflect better mobility
St George's Respiratory function questionnaire
The range is 0 to 100; higher scores worse.
Short Physical Performance Battery (SPPB )
The scores range from 0-12, higher scores reflect better lower extremity function.
The Picture Memory Impairment Screen
The scores range from 0-8, higher scores reflect better memory function.
The Paper Match Stimuli.
The scores range from 0-52, higher scores better processing speed and executive function.
The Beck Depression Inventory (BDI).
The scores range from 0-63. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe depression.
Discharge Destination
Percentage of patients being discharged home, versus those who require discharge to rehabilitation hospitals

Full Information

First Posted
March 11, 2021
Last Updated
March 21, 2022
Sponsor
Montefiore Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT04821531
Brief Title
Feasibility of a Self-guided Exercise Program Among Hospitalized COVID-19 Patients
Official Title
Impact of Adding a Self-guided Exercise Program on Functional Outcomes Among Hospitalized COVID-19 Patients: A Randomized Prospective Study
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Withdrawn
Why Stopped
COVID patients admitted to the hospital during the study dates did NOT have the criteria to enter the study(i.e they were too medically unstable) or their hospital stay was too short to conduct a before and after assessment
Study Start Date
November 2021 (Anticipated)
Primary Completion Date
February 23, 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Montefiore Medical Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The investigators' aim is to conduct a study looking into safety and feasibility study of Covid patients participating in a self-guided exercises program while admitted to the hospital. The investigators will test 2 forms of exercise instruction, one using an exercise phone-based application, and the other a printed exercise manual.
Detailed Description
The COVID-19 pandemic has resulted in significant morbidity and mortality throughout the world. As of March 16, 2021 there were over 119 million confirmed COVID-19 cases and 2.6 million deaths globally. The majority of COVID-19 cases are mild to moderate, resulting in symptom resolution within 6 weeks of symptom onset. Following moderate to severe COVID-19 infections, functional impairments are likely to be dominated by peripheral muscle dysfunction (due to deconditioning and decreased lean body mass, ICU neuropathy, fatigue and the effects of hypoxemia), respiratory muscle dysfunction (dysfunctional breathing pattern, DBP, and exercise-induced laryngeal obstruction), cardiac impairment and deconditioning, and psychosocial factors (anxiety, depression, guilt, sleep disturbance and dependency). Physical exercise has proven to be an effective therapy for most chronic diseases and microbial infections with preventive or therapeutic benefits involving the primary immunological mediators and/or anti-inflammatory properties. Another mechanism is that it can counteract the effect of prolonged bedrest by preventing the decline in muscle strength, muscle mass loss , reduce exaggerated cardiac response to exercise, reduce thromboembolism, and improve lung function. Prior research in COPD patients have shown that early pulmonary rehabilitation showed reductions in mortality, length of stay and readmission. There has been some concern among physicians about allowing patients with COVID-19 to exercise. This is also of concern to all practitioners of Rehabilitation Medicine and the investigators seek to understand the risks better. This research group is currently concluding another retrospective study of 988 COVID-19 patients that suggest that not only is exercise safe, but increasing the number of exercise interventions improves the functional status of the patients and may reduce mortality. As the next step, the investigators propose a 12-month, single blind feasibility study to determine if adding a self-guided exercise to a patient population already receiving two 30-minutes/week therapy can improve the patient's overall functional and cognitive outcomes. The overall hypothesis is that COVID-19 patients admitted to the hospital with mild to moderate disease can safely perform these exercises and improve their physical and cognitive functioning. The objective in performing this study is to examine feasibility as well as obtain preliminary data to design future RCT studies in this or other similar diseases. The self-guided exercise program was developed by the Department of Rehabilitation at Montefiore during the initial COVID-19 surge. The manual has been published in the Journal for the International Society of Physical and Rehabilitation Medicine and has been distributed through many medical society websites. COVID-19 patients admitted to the Montefiore Hospital have been receiving the exercise manual upon discharge for the past 9 months. The exercises in the program are divided into 3 levels. The initial level focuses on prevention of lung complication associated with COVID-19, and prevention of contracture in the large joints associated with bedrest. The next level focuses on improving sitting tolerance, strengthening limb and accessory muscles of breathing. The final level works on standing balance, large muscle strengthening, and building cardiopulmonary endurance The investigators will test 2 modes of delivery, one using the printed exercise manual and the other using Pt PAL, a mobile health technology application. Pt PAL can facilitate communication between the care team and patients, and allows the team to send from their web-portal, exercise routines, surveys and educational material to the patient's mobile device. The Pt PAL app then captures the patient activity adherence, and reports those results back to the team including a graphical summary about patients' condition and activity. The investigators have successfully applied Pt PAL exercise program to other patient populations (e.g., heart failure patients) in Montefiore Medical Center, and the app has received regulatory approval at Montefiore. The research team composed of Rehabilitation Medicine physician, Internal Medicine specialist, rehabilitation therapists, nursing, medical students and research staff are very well positioned to carry out a study of this nature effectively and safely to its conclusion. The investigators will assess the changes in the following measures Activity Measure for Post-Acute Care (AM-PAC)12 which was developed to examine basic mobility and daily activity functional activities important to adults. St George's Respiratory function questionnaire to assess pulmonary function. It is scored for symptoms, physical activity, and impact domains Short Physical Performance Battery (SPPB ) is a series of physical performance tests used in older persons to assess lower extremity function, balance and mobility and is predictive of a broad range of adverse outcomes, including mortality, incident disability, falls, hospitalization and healthcare utilization. The Picture Memory Impairment Screen is a brief, 4-item free and cued recall test of memory that uses pictures to overcome many of the educational, cultural, and logistical barriers to cognitive screening in clinical settings and is nondiscriminatory with regard to culture and literacy. The Paper Match Stimuli, a rapid paper test that can be administered under 3 minutes correlate predominantly with brain regions mediating information processing speed (i.e., basal ganglia) and executive functions (i.e., dorsolateral prefrontal and parietal cortex The Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression, which can help identify patients whose motivation for exercise may be impacted by depression

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Corona Virus Infection
Keywords
coronavirus, covid, covid-19, covid19, corona

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Single blind(outcome assessor)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
PT Pal
Arm Type
Experimental
Arm Description
Experimental Arm-PT PAL Participants randomized into this arm will receive exercise instructions via Pt_PAL. PT PAL is a mobile health technology used to facilitate communications between Care teams and patients, by allowing the team to send web-based exercise routines, surveys and educational materials. The PT Pal app captures patient activity adherence and reports
Arm Title
Exercise Manual
Arm Type
Active Comparator
Arm Description
Control Arm- Exercise Manual Participants randomized into this arm will use the exercise manual to obtain their exercise instructions
Intervention Type
Other
Intervention Name(s)
PT Pal
Intervention Description
Patients will be guided through individualized exercises that will be selected by their primary physical therapists. The exercises aim to improve lung function, maintain joint flexibility, muscle strength balance and mobility
Intervention Type
Other
Intervention Name(s)
Exercise Manual
Intervention Description
Patients will be guided through individualized exercises that will be selected by their primary physical therapists. The exercises aim to improve lung function, maintain joint flexibility, muscle strength, balance and mobility
Primary Outcome Measure Information:
Title
Adherence: Number of Days patient exercises independently at least 1 time a day
Time Frame
1 year
Title
Recruitment , Implementation and Retention: number of patients contacted, enrolled and completed study
Time Frame
1 year
Title
Safety: Number of adverse health events
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Activity Measure for Post-Acute Care (AM-PAC).
Description
The range is 6-24; higher scores reflect better mobility
Time Frame
1 year
Title
St George's Respiratory function questionnaire
Description
The range is 0 to 100; higher scores worse.
Time Frame
1 year
Title
Short Physical Performance Battery (SPPB )
Description
The scores range from 0-12, higher scores reflect better lower extremity function.
Time Frame
1 year
Title
The Picture Memory Impairment Screen
Description
The scores range from 0-8, higher scores reflect better memory function.
Time Frame
1 year
Title
The Paper Match Stimuli.
Description
The scores range from 0-52, higher scores better processing speed and executive function.
Time Frame
1 year
Title
The Beck Depression Inventory (BDI).
Description
The scores range from 0-63. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe depression.
Time Frame
1 year
Title
Discharge Destination
Description
Percentage of patients being discharged home, versus those who require discharge to rehabilitation hospitals
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion COVID-19 Positive by PCR testing Adults aged 50-75 Patients evaluated by Rehabilitation team and found appropriate for the study Able to read and understand English or Spanish Have access to a smartphone Exclusion Pregnant patients Patients with dementia or cognitive dysfunction Patients who exhibit poor safety or unsafe behavior Patients who need high flow oxygen, rebreather or any form of ventilatory support Patients with chest tubes or similar attachments
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anne Felice Ambrose, MD
Organizational Affiliation
Montefiore Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montefiore Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10467
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Feasibility of a Self-guided Exercise Program Among Hospitalized COVID-19 Patients

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